The Drug Supply Chain Security Act has been a decade in the making. Pharmacists must be prepared to comply by November 2023.
The Drug Supply Chain Security Act (DSCSA) will take full effect on November 27, 2023. On that date, manufacturers, distributors, and pharmacies—“dispensers,” in DSCSA parlance—must be able to track, trace, and verify down to the unit level every prescription product they handle and maintain those records for a minimum of 6 years.
“At the dispenser level, DSCSA will largely move pharmacies to formalize policies and procedures they have been doing all along,” explained Lisa Schwartz, PharmD, senior director of Professional Affairs at the National Community Pharmacists Association (NCPA). “Every good pharmacist has ways of segregating product that doesn’t look right and checking back with their wholesalers, making sure they are doing business with legitimate and reputable partners in the supply chain. DSCSA just formalizes what [they’re]…already doing and uses speciﬁc terms like suspect product, quarantine, and investigation to describe the process. Those are the kinds of words that FDA and regulatory inspectors are going to want to see in [pharmacists’] written policies and procedures.”
In more good news for the industry, the DSCSA supersedes the current patchwork of state pedigree requirements. The National Association of Boards of Pharmacy (NABP) has been working with state boards of pharmacy to update inspection standards and procedures, said Josh Bolin, associate executive director for Federal Affairs and Strategy at NABP. “After November 27, 2023, states will be unable to enact any tracing requirements that go beyond the obligations laid out in DSCSA but…will check for DSCSA compliance,” he noted, adding that “one of the open questions is enforcement discretion in the early period. We will continue to work with our partners as November grows closer.”
However, tracking and tracing doesn’t apply to all medications, according to Bolin. Most OTC products, compounded drugs, and veterinary drugs are not included in DSCSA, and pharmacies won’t be required to track prescription drugs down to the patient level, or when selling to another pharmacy for dispensing to a speciﬁc patient.
The DSCSA has its roots in the counterfeit and mislabeled products that entered the US supply chain during the 1990s and early 2000s, said Ilisa Bernstein, PharmD, JD, senior vice president of Pharmacy Practice and Government Affairs at the American Pharmacists Association (APhA). Health-system, chain, and independent pharmacies were all reporting problems back then. “[For nearly 10 years,] there were attempts to voluntarily track and trace drugs through the supply chain,” Bernstein observed during an APhA webinar on DSCSA in February 2023. “But the supply chain is huge, and putting something in place voluntarily just didn’t work. Congress stepped in and legislated drug supply chain security in 2013.”
Enacted in 2013 with a 10-year implementation timeline, the DSCSA had as its goal the creation of a secure electronic, interoperable system for exchanging transaction information (TI), transaction history (TH), and transaction statements (TS) that would allow regulators and all parties in the pharmaceutical supply chain to track and trace every prescription package. Manufacturers, distributors, wholesalers, repackagers, third-party logistics suppliers, and dispensers must all be registered and licensed under DSCSA to become authorized trading partners (ATPs).
Whether buying, selling, exchanging, returning, repackaging, or destroying prescription products, pharmacies and other entities in the supply chain must verify the legitimacy of their ATPs. All ATPs must report any suspicious or illicit package(s) to the FDA and to other trading partners along the chain of supply for the given product.
In 2015, manufacturers and wholesale distributors implemented traceability at the lot level with TI, TH, and TS; in 2017, manufacturers added product identiﬁers to the smallest saleable unit or package and to each homogeneous case of product, and in 2018 repackagers did the same. Beginning in 2019, wholesale distributors could accept and distribute only serialized product. Veriﬁcation was scheduled to apply to dispensers like pharmacies in 2020, but the COVID-19 pandemic prompted the FDA to delay enforcement until 2023.
Pharmacies are not on their own when conforming to DSCSA requirements. Dispensers—and the rest of the supply chain—rely on the information they exchange with other ATPs. “DSCSA is interdependent,” noted Elizabeth Gallenagh, JD, general counsel and senior vice president for Supply Chain Integrity at the Healthcare Distribution Alliance (HDA). “Each trading partner is dependent on what they can get from the partner above and below them in the supply chain.”
Thus, DSCSA highlights 2 areas of concern for independent pharmacists. One pertains to what happens in the pharmacy: Are you prepared? Do you have the technology? Do you know your products and suppliers? Are you ready to implement the pol-icies that will make you compliant? The other has to do with the rest of the supply chain: even if individual pharmacies are ready, their ATPs may not be.
“From the distributor perspective, [HDA]…our members are not getting 100% of data…from manufacturers at this point,” Gallenagh pointed out, although “each week [that goes by]…we know a little more, but we are all codependent on other players to get DSCSA right.”
Most pharmacies, however, are ready. The results of nearly 1200 NABP inspections conducted between 2018 and 2022 found that 79% of pharmacies already had a documented process for vetting ATPs and product, Bolin reported. Nonetheless, only 56% of pharmacies are actually following their own policies and routinely veri-fying ATPs. Half of inspected pharmacies (52%) did not routinely verify that they were getting the required TI, TH, and TS before accepting shipments.
“DSCSA would have been more of a focus for pharmacists had they not been completely under water during the pandemic,” said Jillane Schulte Wall, JD, senior director of Health & Regulatory Policy at the American Society of Health-System Pharmacists. “Pharmacists everywhere—hospitals, health systems, independents, [and] chains—are still in catch-up mode after 3 years that were a black hole for everyone. We’re all scrambling with DSCSA.”
Most prescription product coming into pharmacies is already DSCSA-compliant, said Connie T. Jung, PhD, RPh, senior advisor for Policy in the Office of Drug Security, Integrity, and Response at the FDA Center for Drug Evaluation and Research, during an APhA webinar in February. Each product package and homogeneous case carries a label containing the national drug code, package serial number, lot number, and expiration date in 2D barcodes that are readable by people and machines.
As long as pharmacies have up-to-date technology, they should be
ready to accept and work with all the transaction information required by the DSCSA. It’s the maintaining of the information that may present a problem. All DSCSA-related records must be retained for 6 years. But how theyose records are maintained is up to each pharmacy. “[The] FDA is not going to mandate one particular technological approach,” Jung said. “Pharmacies can work with their solution provider or their wholesale distributor or some other third party. And they may choose to do it in-house as well. We are not going to be prescriptive.”
The NABP, NCPA, and other pharmacy groups are creating their own compliance solutions or partnering with data vendors. “There are DSCSA compliance solution providers out there that will help pharmacies receive and organize the information,” Wall said. “A third-party provider may be especially helpful for pharmacies that deal with multiple suppliers.”
Pharmacies should be updating standard operating procedures (SOPs) to ensure that workflows and processes are compliant with—and explicitly reference—DSCSA.
“It’s not just that you are complying with DSCSA but that you are using the DSCSA terminology that inspectors are looking for,” Schwartz said. “You probably already have a tote or a shelf you use to separate…questionable product that comes from your wholesaler, and you do your due diligence to verify anything that is questionable before ou put product on the shelf.
“With DSCSA, your SOP has to specify procedures to inspect product coming in, quarantine product that is suspect, investigate anything that appears to be suspect or illegitimate, and report illegitimate product to FDA and your ATPs within a specified timeframe,” she added. “And training records for every staff member will have to reflect training on the most recent SOPs.”
Enforcement is another crucial unknown. APhA has petitioned the FDA for DSCSA enforcement discretion for pharmacies with 25 or fewer employees. HDA is requesting enforcement discretion for the entire supply chain while DSCSA kinks are being worked out. The agency had not responded as of deadline.
Stakeholders are updating their DSCSA information and FAQs as quickly as they can. DSCSAEdu, an industry-wide portal, is the single best source for current information. The NCPA provides an exhaustive checklist and SOP considerations on its website. (See below for more resources.)
Perhaps most important, pharmacists should be ready for DSCSA not to work as expected at the beginning.
DSCSAEdu is a collaborative online resource developed by the American Pharmacists Association, the American Society of Health-System Pharmacists, the National Community Pharmacists Association, the National Association of Boards of Pharmacy, the Healthcare Distribution Alliance, and other industry partners to keep dispensers in the information loop as DSCSA moves toward complete implementation.
The National Association of Boards of Pharmacy has dedicated a page to the DSCSA, which is available on its website.
And the National Community Pharmacists Association offers a printable document on standard operating procedures and considerations under DSCSA.